Sebia FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument510(k)Apr 4, 2024Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Apr 4, 2024
FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2510(k)Feb 23, 2024Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2510(k)Nov 18, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
HYDRASHIFT 2/4 isatuximab510(k)Nov 12, 2021Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Nov 12, 2021